Carcinoembryonic Antigen as a Predictive Biomarker of Response to Nivolumab in Non-small Cell Lung Cancer.

AIM: To find new predictive factors for the efficient use of immune checkpoint inhibitors in patients with non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: In this multicenter retrospective cohort study, we evaluated consecutive patients treated with nivolumab between January and October 2016 after second-line systemic chemotherapy. The endpoint was progression-free survival (PFS), as defined by Response Evaluation Criteria in Solid Tumors version 1.1. RESULTS: A total of 189 patients were included in the study. Sixty-four percent had received two or more prior systemic therapies. In Cox proportional hazard analyses, Eastern Cooperative Oncology Group Performance Status of 2 or more, lactate dehydrogenase (LDH) ≥217 mg/dl, and carcinoembryonic antigen ≥13.8 ng/ml were independently associated with inferior PFS. LDH was not associated in the sensitivity analysis. CONCLUSION: In patients with NSCLC treated with nivolumab, worse pretreatment performance status, and higher carcinoembryonic antigen were associated with inferior PFS.

Concordance between the response evaluation criteria in solid tumors version 1.1 and the immune-related response criteria in patients with non-small cell lung cancer treated with nivolumab: a multicenter retrospective cohort study.

PURPOSE: The immune-related response criteria (irRC) were proposed to incorporate pseudo-progression. However, the association between the irRC and overall survival (OS) has yet to be evaluated in non-small cell lung cancer (NSCLC). Therefore, the purpose of this study is to evaluate the concordance between the response evaluation criteria in solid tumors (RECIST) version 1.1 and the irRC in patients with NSCLC treated with nivolumab, as well as, to determine the relationship between these two response criteria and OS. METHODS: We conducted a retrospective cohort study of 143 patients at three tertiary care hospitals in Japan between January and December 2016 (UMIN000022014). RESULTS: The weighted kappa statistic for the two response criteria was 0.72 (95% confidence interval (CI) 0.66-0.76). The Harrell's C-index was 0.74 (95% CI 0.68-0.80) for the RECIST and 0.74 (95% CI 0.68-0.80) for the irRC, respectively. The difference between the two criteria was - 0.002 (95% CI - 0.05 to 0.04). The Moreau, O'Quigley, and Lellouch statistic was 0.03 for the RECIST and 0.17 for the irRC, respectively. CONCLUSION: We demonstrated a good concordance between the RECIST and the irRC for predicting OS in patients with NSCLC treated with nivolumab.

Retrospective study of unplanned hospital admission for metastatic cancer patients visiting the emergency department.

PURPOSE: The purpose of the study was to identify factors that predict unplanned admission for metastatic cancer patients visiting the emergency department (ED). METHODS: Patients visiting the ED of a general hospital from April 2012 to March 2013 were investigated retrospectively. Data including demographics, vital signs, and laboratory measurements were collected from a chart review for each patient. Factors related to emergency admission were identified by univariate and multivariate analyses. RESULTS: A total of 15,716 individuals visiting the ED during the study period included 1244 (7.9%) patients with cancer. Among the 491 cancer patients with metastasis, univariate analysis revealed that emergency admission was significantly associated with an age of ≥76 years; an altered mental status; fever (≥38 °C); a blood oxygen saturation of <90%; a white blood cell (WBC) count of ≤2000 or ≥10,000/µL; hypoalbuminemia (≤2.5 g/dL); and elevated levels of aspartate aminotransferase (≥100 IU/L), blood urea nitrogen (≥25 mg/dL), and C-reactive protein (CRP, ≥10 mg/dL). Multivariate analysis identified age, an altered mental status, hypoxemia, an abnormal WBC count, and elevated CRP as putative independent predictive factors for emergency admission. The number of these five factors present was also correlated with 30-day mortality (c-statistic = 0.72). CONCLUSIONS: Age, unconsciousness, hypoxemia, an abnormal WBC count, and elevated CRP were found to be associated with emergency admission and 30-day mortality for metastatic cancer patients. Prospective validation of a predictive scoring system based on these findings is warranted.